EXPLANATORY STATEMENT
THERAPEUTIC GOODS (LISTING) NOTICE 2011 (NO. 1)
Leptospermum scoparium oil
Subsection 9A(5), Therapeutic Goods Act 1989
OUTLINE
Therapeutic Goods (Listing) Notice 2011 (No. 1) (the Listing Notice) is a notice made by the delegate of the Minister for Health and Ageing under subsection 9A(5) of the Therapeutic Goods Act 1989 (the Act).
The Listing Notice has the effect of requiring that therapeutic goods that contain ‘Leptospermum scoparium oil’ as an active ingredient, presented as topical or mouthwash preparations as described in the notice, be included in the part of the Australian Register of Therapeutic Goods (the Register) for listed goods.
The Listing Notice commenced on the day after it was registered on the Federal Register of Legislative Instruments.
BACKGROUND
The Act provides for the establishment and maintenance of a national system of controls for the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia. The Therapeutic Goods Administration (the TGA) is responsible for administering the Act.
Unless specifically exempted or authorised under the Act, therapeutic goods are required to be included on the Register before being supplied in, imported into, manufactured in or exported from Australia (sections 19B and 19D of the Act). Medicines are registered or listed on the Register, depending on the ingredients they contain and the therapeutic claims that are being made.
In general, products that contain low risk ingredients are referred to as listed medicines in Australia. Most listed medicines are considered to be of relatively low risk compared to other types of medicines, such as prescription and over-the-counter medicines, as they may only contain ingredients that have been approved by the TGA as being of low risk and may only make limited therapeutic claims.
Part 1 of Schedule 4 to the Therapeutic Goods Regulations 1990 (the Regulations) sets out those therapeutic goods that are required to be included in the part of the Register for listed medicines. It does not currently include goods that contain ‘Leptospermum scoparium oil’ as a therapeutically active ingredient presented as topical or mouthwash preparations.
Subsection 9A(5) of the Act authorises the Minister for Health and Ageing to publish a notice in the Commonwealth of Australia Gazette requiring that specified goods be included in the part of the Register for listed goods. Such notices generally require that goods containing particular ingredients be included in that part of the Register. Once the notice is in effect, persons may apply for the listing on the Register of new therapeutic goods that contain ingredients or substances of the kind set out in the notice.
Should Part 1 of Schedule 4 to the Regulations be amended to require goods that are the subject of a subsection 9A(5) notice to be included in the part of the Register for listed goods, the notice ceases to have effect (subsection 9A(6) of the Act).
A person can apply for a new ingredient or substance to be specified in a notice under subsection 9A(5). The TGA evaluates such applications and the supporting data provided by the applicant on the basis of safety and quality. The safety-focussed element determines whether the ingredient or substance is of sufficiently low risk to allow its inclusion in listed medicines and the quality-focussed element characterises the precise and correct nature of the ingredient or substance. Once the notice is in effect, applications can be made for the listing on the Register of new therapeutic goods that contain ingredients/substances of the kind set out in the notice.
LEPTOSPERMUM SCOPARIUM OIL
Leptospermum scoparium oil is the essential oil of Leptospermum scoparium (commonly called ‘manuka’) derived from the leaves and terminal branchlets, which are wild-harvested from the Te Araroa region of the East Cape of New Zealand.
L. scoparium oil was included in Schedule 6 to the Standard for Uniform Scheduling of Medicines and Poisons (SUSMP)[1], to operate from 1 January 2011 with exceptions including preparations containing 25 per cent or less of L. scoparium oil and medicines for human therapeutic use that meet certain requirements based on restricted volumes, restricted-flow inserts, child-resistant closures and labelling.
The delegate of the Minister has determined that the ingredient L. scoparium oil should be included in the part of the Register for listed goods when included in topical or mouthwash preparations, appropriately presented, that is, when it is of sufficiently low concentration (25 per cent or less of L. scoparium oil) and, irrespective of the concentration, when presented in low volumes with appropriate packaging. In these presentations, the risk of accidental poisoning, especially to children, is sufficiently reduced to allow the goods containing L. scoparium oil to be included on the Register as listed medicines which are topical or mouthwash preparations.
The TGA has prepared a physico-chemical description of L. scoparium oil in the form of compositional guidelines. Compositional guidelines are intended to assist applicants for inclusion of therapeutic goods on the Register that are or include goods of the kind described in a subsection 9A(5) notice in identifying the specific forms or types of ingredients or substances where, as in this case, there is no standard in the British Pharmacopoeia or other acceptable monographs in relation to an ingredient or substance.
The draft compositional guidelines for L. scoparium oil are available on the TGA’s internet site (www.tga.gov.au) for consultation for six weeks from the date of registration of the Listing Notice. The guidelines will then be published on the website in their final form.
CONSULTATION
The making of the Listing Notice is minor and machinery in nature with no or low compliance costs and impact on business, individuals or the economy.
[1] Schedule 6 lists substances that are classified as ‘poisons’ on the basis that they have a moderate potential for causing harm, the extent of which can be reduced through the use of appropriate packaging with simple warnings and safety directions on the label.